Calquence
acalabrutinib
Table of contents
Overview
Calquence is a cancer medicine used to treat adults with chronic lymphocytic leukaemia (CLL), a blood cancer affecting B cells (a type of white blood cell).
Calquence is used on its own (monotherapy) in patients with CLL who have had previous treatment. In patients who have not had previous treatment for the condition, Calquence may be used on its own or combined with another cancer medicine, obinutuzumab.
Calquence contains the active substance acalabrutinib.
-
List item
Calquence : EPAR - Medicine overview (PDF/109.96 KB)
First published: 11/11/2020
EMA/457460/2020 -
-
List item
Calquence : EPAR - Risk-management-plan summary (PDF/141.73 KB)
First published: 11/11/2020
Last updated: 06/03/2023
Authorisation details
Product details | |
---|---|
Name |
Calquence
|
Agency product number |
EMEA/H/C/005299
|
Active substance |
Acalabrutinib
|
International non-proprietary name (INN) or common name |
acalabrutinib
|
Therapeutic area (MeSH) |
Leukemia, Lymphocytic, Chronic, B-Cell
|
Anatomical therapeutic chemical (ATC) code |
L01EL02
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
---|---|
Marketing-authorisation holder |
AstraZeneca AB
|
Revision |
6
|
Date of issue of marketing authorisation valid throughout the European Union |
05/11/2020
|
Contact address |
151 85 Sodertalje |
Product information
14/06/2023 Calquence - EMEA/H/C/005299 - IB/0020
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antineoplastic agents, protein kinase inhibitors
Therapeutic indication
Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.